BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE PUMP ADMINISTRATION SET

    MDR report key: 1813203 · Received August 19, 2010

    Report

    Report Number
    9616066-2010-00213
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 19, 2010
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATED AND CUSTOMER'S EXPERIENCE OF LEAKAGE AT THE DRIP CHAMBER JOINT WAS CONFIRMED. THE CAUSE OF THE LEAK WAS IDENTIFIED AS INSUFFICIENT APPLICATION OF SOLVENT AT THE AFFECTED JOINT DURING THE MFG PROCESS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO QUALITY ISSUES WERE NOTED DURING PRODUCTION BUILD FOR THE LOT NUMBER REPORTED.

    Description of Event or Problem · 1

    THE USER REPORTED A LEAK OF AN UNSPECIFIED SOLUTION AT THE DRIP CHAMBER JOINT DURING USE. NO ADD'L INFO WAS PROVIDED. FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE PUMP ADMINISTRATION SET FPA CAREFUSION CORP. 71980 09046085

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK